Trial Outcomes & Findings for REduCing Immunogenicity to PegloticasE (RECIPE) Study (NCT NCT03303989)
NCT ID: NCT03303989
Last Updated: 2022-03-16
Results Overview
Proportion of participants achieving and maintaining an sUA ≤ to 6 mg/dL through 12 weeks, compared to concurrent controls.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-03-16
Participant Flow
Participant milestones
| Measure |
Pegloticase + MMF
Participants randomized to this arm will receive pegloticase + mycophenolate mofetil.
Pegloticase 8 MG/ML \[Krystexxa\]: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
MMF: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
|
Pegloticase + Placebo
Participants randomized to this arm will receive pegloticase + placebo
Placebo: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
Pegloticase 8 MG/ML \[Krystexxa\]: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
11
|
|
Overall Study
COMPLETED
|
22
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
REduCing Immunogenicity to PegloticasE (RECIPE) Study
Baseline characteristics by cohort
| Measure |
Pegloticase + MMF
n=22 Participants
Participants randomized to this arm will receive pegloticase + mycophenolate mofetil.
Pegloticase 8 MG/ML \[Krystexxa\]: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
MMF: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
|
Pegloticase + Placebo
n=10 Participants
Participants randomized to this arm will receive pegloticase + placebo
Placebo: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
Pegloticase 8 MG/ML \[Krystexxa\]: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
55.5 years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
55.2 years
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
10 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
American College of Rheumatology / European League Against Rheumatism Flare Criteria Score
|
13.5 Score on a scale
STANDARD_DEVIATION 2.8 • n=99 Participants
|
13.8 Score on a scale
STANDARD_DEVIATION 2.7 • n=107 Participants
|
13.5 Score on a scale
STANDARD_DEVIATION 2.6 • n=206 Participants
|
|
Gout Flare History (flare within the last year)
Yes
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Gout Flare History (flare within the last year)
No
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Duration of Gout
|
13.3 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
13.4 years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
13.4 years
STANDARD_DEVIATION 9.0 • n=206 Participants
|
|
PROMIS Pain Intensity
|
50.8 units on a scale
STANDARD_DEVIATION 11.3 • n=99 Participants
|
45.0 units on a scale
STANDARD_DEVIATION 12.4 • n=107 Participants
|
49.0 units on a scale
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
PROMIS Physical Function
|
37.5 units on a scale
STANDARD_DEVIATION 7.8 • n=99 Participants
|
33.8 units on a scale
STANDARD_DEVIATION 6.4 • n=107 Participants
|
36.3 units on a scale
STANDARD_DEVIATION 8.6 • n=206 Participants
|
|
Gout Impact Score
|
45.7 Score on a scale
STANDARD_DEVIATION 7.5 • n=99 Participants
|
46.4 Score on a scale
STANDARD_DEVIATION 7.1 • n=107 Participants
|
45.9 Score on a scale
STANDARD_DEVIATION 7.3 • n=206 Participants
|
|
Serum Urate Level
|
8.9 mg/dL
STANDARD_DEVIATION 1.8 • n=99 Participants
|
9.8 mg/dL
STANDARD_DEVIATION 1.3 • n=107 Participants
|
9.2 mg/dL
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Body Mass Index
25 to < 30
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Body Mass Index
30 to < 45
|
18 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Body Mass Index
≥45
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Comorbidities
Diabetes Mellitus /Metabolic Syndrome · Yes
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Comorbidities
Diabetes Mellitus /Metabolic Syndrome · No
|
19 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Comorbidities
Cerebral Vascular Vascular Disease/Heart Accident/Peripheral Vascular Disease · Yes
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Comorbidities
Cerebral Vascular Vascular Disease/Heart Accident/Peripheral Vascular Disease · No
|
14 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Comorbidities
Systemic Hypertension · Yes
|
18 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Comorbidities
Systemic Hypertension · No
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Comorbidities
Dyslipidemia · Yes
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Comorbidities
Dyslipidemia · No
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Comorbidities
Kidney Stones · Yes
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Comorbidities
Kidney Stones · No
|
18 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 32 participants received at least one dose of pegloticase and were included in modified intention-to-treat analyses.
Proportion of participants achieving and maintaining an sUA ≤ to 6 mg/dL through 12 weeks, compared to concurrent controls.
Outcome measures
| Measure |
Pegloticase + MMF
n=22 Participants
Participants randomized to this arm will receive pegloticase + mycophenolate mofetil.
Pegloticase 8 MG/ML \[Krystexxa\]: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
MMF: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
|
Pegloticase + Placebo
n=10 Participants
Participants randomized to this arm will receive pegloticase + placebo
Placebo: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
Pegloticase 8 MG/ML \[Krystexxa\]: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
|
|---|---|---|
|
Proportion of Participants Achieving and Maintaining an sUA ≤ to 6 Milligram Per Deciliter (mg/dL) Through 12 Weeks
Yes
|
19 Participants
|
4 Participants
|
|
Proportion of Participants Achieving and Maintaining an sUA ≤ to 6 Milligram Per Deciliter (mg/dL) Through 12 Weeks
No
|
3 Participants
|
6 Participants
|
Adverse Events
Pegloticase + MMF
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Pegloticase + Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pegloticase + MMF
n=22 participants at risk
Participants randomized to this arm will receive pegloticase + mycophenolate mofetil.
Pegloticase 8 MG/ML \[Krystexxa\]: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
MMF: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
|
Pegloticase + Placebo
n=10 participants at risk
Participants randomized to this arm will receive pegloticase + placebo
Placebo: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
Pegloticase 8 MG/ML \[Krystexxa\]: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Infusion Reaction
|
0.00%
0/22 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
10.0%
1/10 • Number of events 1 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
|
Injury, poisoning and procedural complications
Motor Vehicle Crash
|
4.5%
1/22 • Number of events 1 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
0.00%
0/10 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
|
Cardiac disorders
Chest Pain
|
4.5%
1/22 • Number of events 1 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
0.00%
0/10 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.5%
1/22 • Number of events 1 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
0.00%
0/10 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
Other adverse events
| Measure |
Pegloticase + MMF
n=22 participants at risk
Participants randomized to this arm will receive pegloticase + mycophenolate mofetil.
Pegloticase 8 MG/ML \[Krystexxa\]: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
MMF: Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
|
Pegloticase + Placebo
n=10 participants at risk
Participants randomized to this arm will receive pegloticase + placebo
Placebo: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
Pegloticase 8 MG/ML \[Krystexxa\]: Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
|
|---|---|---|
|
Cardiac disorders
Cardia
|
9.1%
2/22 • Number of events 2 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
10.0%
1/10 • Number of events 1 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
|
Gastrointestinal disorders
Gastrointestinal
|
18.2%
4/22 • Number of events 4 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
10.0%
1/10 • Number of events 1 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
|
Infections and infestations
Infections
|
9.1%
2/22 • Number of events 2 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
0.00%
0/10 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal (arthralgia, myalgia, low back pain, orthopedic trauma, bursitis tendonitis)
|
40.9%
9/22 • Number of events 19 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
10.0%
1/10 • Number of events 2 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
|
Skin and subcutaneous tissue disorders
Skin
|
9.1%
2/22 • Number of events 2 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
10.0%
1/10 • Number of events 1 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
|
General disorders
Other (Lab abnormality, anxiety, neurological, and oral pain)
|
40.9%
9/22 • Number of events 11 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
50.0%
5/10 • Number of events 5 • 36 weeks
Adverse event was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Adverse Events were monitored/assessed based on organ system class.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER